StrokeSLEEPRNCT05012605
The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
An observational study of Stroke and Sleep Wake Disorders, run by State University of New York - Upstate Medical University at 6 sites in United States.
Trial summary
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sleep Wake Disorders, Rehabilitation
- What is being tested?
- Observation
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Mar 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults recovering from stroke within the first 90 days following stroke who did not have a diagnosis of obstructive sleep apnea (OSA) prior to stroke or who do not have oxygen desaturation index (ODI) of 15 or higher during inpatient rehabilitation (~15 days post-stroke).
Who may be able to join
- Diagnosis of stroke as defined by the WHO: "a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function and persisting longer than 24 hours." Diagnosis of stroke will be confirmed by imaging or clinical diagnosis.
- Age 18 or older.
- Admitted to in-patient rehabilitation.
- National Institutes of Health Stroke Scale (NIHSS) item 1a score <2 (Level of consciousness: 0=alert, 1=not alert, but arousable by minor stimulation to obey, answer, or respond).
- Provision of informed consent by individual or by legally authorized representative.
Who cannot join
- Pre-stroke or current diagnosis of OSA or other sleep-related breathing disorder.
- Living in a nursing home or assisted living center prior to the stroke.
- Unable to ambulate 150' independently prior to the stroke.
- Other neurologic health condition that may impact recovery such as Parkinson Disease, Multiple Sclerosis, Traumatic Brain Injury, Alzheimer's Disease.
- Women who are pregnant.
- Recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure.
Show all 9Show fewer
- Planned discharge location >150 miles radius from recruitment site
- Global aphasia as defined by a NIHSS item 9 score of 3 (3= Mute, global aphasia; no usable speech or auditory comprehension).
- Inability to understand English
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 3 recruiting
- Terminated
Good Shepherd Rehabilitation Network
Allentown, Pennsylvania, 17193
- Recruiting
Emory University
Atlanta, Georgia, 39322
George D Fulk, PhD PT, 404-727-9807
- Recruiting
KU Medical Center, The University of Kansas
Kansas City, Kansas, 66160
Sandra A Billinger, PhD, 913-588-5000, sbillinger@kumc.edu
- Active, not recruiting
Institute for Human Performance - Upstate Rehabilitation at IHP
Syracuse, New York, 13210
- Recruiting
Upstate University Hospital
Syracuse, New York, 13210
Karen J Klingman, PhD, 315-464-4276, klingmak@upstate.edu
- Suspended
Upstate Community Hospital
Syracuse, New York, 13215
About this study
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke.
Read the detailed description
The overall goal in this project is to develop an in-depth understanding of the complex interplay between non-obstructive sleep apnea (non OSA) sleep disorders and recovery after stroke. Sleep is vital to overall health and quality of life. Abnormal or insufficient sleep is both a risk factor and consequence of stroke. Sleep also plays a critical role in motor learning, which is the foundation of rehabilitation strategies after stroke. Although there is a growing understanding of the interplay between sleep, stroke, and recovery in people with OSA these complex relationships in individuals post stroke with non OSA sleep disorders are not well understood. In order to develop targeted sleep interventions to support rehabilitation after stroke and promote optimal recovery, it is critical to gain a fuller understanding of the prevalence and impact of non OSA sleep disorders in people with stroke across the continuum of recovery. The specific objectives of this proposal will lay the necessary groundwork for this as investigators will characterize the proportion of people with stroke that have insomnia disorders, restless legs syndrome, and insufficient sleep; and evaluate the impact of these non OSA sleep disorders on recovery of activities of daily living, mobility/activity, and participation across the continuum of recovery after stroke. The study will take an innovative approach to measuring sleep, mobility/activity, and participation using a combination of techniques across the measurement spectrum that will include self-report questionnaires, clinic-based measures of capacity, and body worn sensors. The body worn sensors will include actigraphy to measure sleep parameters, activity monitors to measure mobility/activity levels, and Global Positioning System (GPS) units to measure participation. Additionally, investigators will apply innovative, big data tools from topological data analysis for a data driven approach to discover complex, structural, non-linear interdependent relationships among stroke, sleep, and recovery of mobility/activity, and participation. Upon completion of this study there will be an understanding of the prevalence and impact of non-OSA sleep disorders on recovery of function, mobility/activity, and participation across the continuum of recovery post stroke. This is an important, necessary step to develop appropriate sleep-based interventions to complement targeted rehabilitation strategies to enhance the health and quality of life in people with stroke.
- Conditions
- Stroke, Sleep Wake Disorders, Rehabilitation, Recovery of Function
- Being tested
- Observation
- Keywords
- Longitudinal study, actigraphy, spatial analysis, patient reported outcome measures, wearable electronic devices
- Medical subject headings
- Stroke, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observe physical function and sleep disorder symptoms following stroke
| Study group | Role | What they receive |
|---|---|---|
| SLEEPR cohort | Individuals within first 3 months following stroke who did not have obstructive sleep apnea within the first 15 days following stroke Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence with activities of daily living as measured by the Barthel index
The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence
Measured: 15 days post-stroke
Functional independence with activities of daily living as measured by the Barthel index
The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence
Measured: 60 days post-stroke
Functional independence with activities of daily living as measured by the Barthel index
The Barthel index is a measure of functional independence with activities of daily living; the score ranges 0-100 with higher numbers indicating more independence
Measured: 90 days post-stroke
Level of disability according to the stroke impact scale
The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function
Measured: 60 days post-stroke
Level of disability according to the stroke impact scale
The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function
Measured: 90 days post-stroke
Daytime sleepiness according to the Epworth Sleepiness Scale
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Measured: 15 days post-stroke
Daytime sleepiness according to the Epworth Sleepiness Scale
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Measured: 60 days post-stroke
Daytime sleepiness according to the Epworth Sleepiness Scale
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Measured: 90 days post-stroke
Insomnia severity as determined from the insomnia severity index
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Measured: 15 days post-stroke
Insomnia severity as determined from the insomnia severity index
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Measured: 60 days post-stroke
Insomnia severity as determined from the insomnia severity index
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Measured: 90 days post-stroke
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Measured: 15 days post-stroke
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Measured: 60 days post-stroke
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Measured: 90 days post-stroke
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Measured: 15days post-stroke
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Measured: 60days post-stroke
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Measured: 90 days post-stroke
Secondary outcomes (31)
Degree of disability according to the modified Rankin scale
the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability
Measured: 15 days post-stroke
Degree of disability according to the modified Rankin scale
the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability
Measured: 60 days post-stroke
Degree of disability according to the modified Rankin scale
the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability
Measured: 90 days post-stroke
Balance ability according to the Berg balance scale
The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance
Measured: 15 days post-stroke
Balance ability according to the Berg balance scale
The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance
Measured: 60 days post-stroke
Balance ability according to the Berg balance scale
The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance
Measured: 90 days post-stroke
Gait speed
Objective measure of gait speed from 10 meter walk test
Measured: 15 days post-stroke
Gait speed
Objective measure of gait speed from 10 meter walk test
Measured: 60 days post-stroke
Gait speed
Objective measure of gait speed from 10 meter walk test
Measured: 90 days post-stroke
Activity level
Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.
Measured: 15 days post-stroke
Activity level
Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.
Measured: 60 days post-stroke
Activity level
Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.
Measured: 90 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data
Objective measure of location of participant over a one week timeframe
Measured: 60 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data
Objective measure of location of participant over a one week timeframe
Measured: 90 days post-stroke
GG code for Mobility and Self Care Sections
Self care and functional mobility codes extracted from participants' medical records
Measured: 15 days post-stroke
Daily activities as recorded by study participants (trip log)
tabulation of trip log - record of when they leave the house and where they are going.
Measured: 60-days post-stroke
Daily activities as recorded by study participants (trip log)
tabulation of trip log - record of when they leave the house and where they are going.
Measured: 90-days post-stroke
Cognitive ability according to the Montreal cognitive assessment
the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.
Measured: 15 days post-stroke
Cognitive ability according to the Montreal cognitive assessment
the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.
Measured: 60 days post-stroke
Cognitive ability according to the Montreal cognitive assessment
the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.
Measured: 90 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression
Measured: 15 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression
Measured: 60 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression
Measured: 90 days post-stroke
Sleep diary
Tabulation of participant's sleep habits from a written diary, over a one week timeframe.
Measured: 60 days post-stroke
Sleep diary
Tabulation of participant's sleep habits from a written diary, over a one week timeframe.
Measured: 90 days post-stroke
Oxygen desaturation index
Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight
Measured: 90 days post-stroke
Oxygen desaturation index
Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight
Measured: 60 days post-stroke
Oxygen desaturation index
Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight
Measured: 15 days post-stroke
Wrist actigraphy data
Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm
Measured: 15 days post-stroke
Wrist actigraphy data
Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm
Measured: 60 days post-stroke
Wrist actigraphy data
Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm
Measured: 90 days post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start25 Mar 2021
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen J. Klingman PhD RN, State University of New York - Upstate Medical University
- Investigators
- Karen J Klingman, PhD, Principal investigator, SUNY Upstate Medical University, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012605
- Sponsor's protocol ID
- R01NR018979
- Acronym
- SLEEPR
- Status last verified
- May 2024
- First submitted
- 9 Aug 2021
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data along with meta-data and descriptors will be shared to the maximum extent possible while protecting patient privacy. Data will be for individual subjects. No aggregate data will be provided apart from what is published in the literature. Data will be formatted for SPSS and/or as csv files.
Publications
Fulk GD, Bell R, Batts K, Klingman K, Peterson E. Sleep Regularity Index After Stroke: Change Over Time and Its Association With Recovery: A Longitudinal Observational Study. J Am Heart Assoc. 2026 Jun 16;15(12):e048392. doi: 10.1161/JAHA.125.048392. Epub 2026 Jun 9.
PubMed 42261959Fulk GD, Klingman K, Peterson EN. Fusing GPS, Activity Monitors, and Self-Report to Improve Assessment of Walking Activity and Community Participation After Stroke. J Neurol Phys Ther. 2025 Jul 1;49(3):128-136. doi: 10.1097/NPT.0000000000000518. Epub 2025 May 8.
PubMed 40336157Klingman KJ, Skufca JD, Duncan PW, Wang D, Fulk GD. Study Protocol: Sleep Effects on Poststroke Rehabilitation Study. Nurs Res. 2022 Nov-Dec 01;71(6):483-490. doi: 10.1097/NNR.0000000000000611. Epub 2022 Aug 6.
PubMed 35948301
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05012605
- Acronym / sponsor ID
- SLEEPR / R01NR018979
- Conditions
- Stroke, Sleep Wake Disorders, Rehabilitation, Recovery of Function
- Keywords
- Longitudinal study, actigraphy, spatial analysis, patient reported outcome measures, wearable electronic devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke.
Detailed description
The overall goal in this project is to develop an in-depth understanding of the complex interplay between non-obstructive sleep apnea (non OSA) sleep disorders and recovery after stroke. Sleep is vital to overall health and quality of life. Abnormal or insufficient sleep is both a risk factor and consequence of stroke. Sleep also plays a critical role in motor learning, which is the foundation of rehabilitation strategies after stroke. Although there is a growing understanding of the interplay between sleep, stroke, and recovery in people with OSA these complex relationships in individuals post stroke with non OSA sleep disorders are not well understood. In order to develop targeted sleep interventions to support rehabilitation after stroke and promote optimal recovery, it is critical to gain a fuller understanding of the prevalence and impact of non OSA sleep disorders in people with stroke across the continuum of recovery. The specific objectives of this proposal will lay the necessary groundwork for this as investigators will characterize the proportion of people with stroke that have insomnia disorders, restless legs syndrome, and insufficient sleep; and evaluate the impact of these non OSA sleep disorders on recovery of activities of daily living, mobility/activity, and participation across the continuum of recovery after stroke. The study will take an innovative approach to measuring sleep, mobility/activity, and participation using a combination of techniques across the measurement spectrum that will include self-report questionnaires, clinic-based measures of capacity, and body worn sensors. The body worn sensors will include actigraphy to measure sleep parameters, activity monitors to measure mobility/activity levels, and Global Positioning System (GPS) units to measure participation. Additionally, investigators will apply innovative, big data tools from topological data analysis for a data driven approach to discover complex, structural, non-linear interdependent relationships among stroke, sleep, and recovery of mobility/activity, and participation. Upon completion of this study there will be an understanding of the prevalence and impact of non-OSA sleep disorders on recovery of function, mobility/activity, and participation across the continuum of recovery post stroke. This is an important, necessary step to develop appropriate sleep-based interventions to complement targeted rehabilitation strategies to enhance the health and quality of life in people with stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLEEPR cohort | – | Other: ObservationIndividuals within first 3 months following stroke who did not have obstructive sleep apnea within the first 15 days following stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults recovering from stroke within the first 90 days following stroke who did not have a diagnosis of obstructive sleep apnea (OSA) prior to stroke or who do not have oxygen desaturation index (ODI) of 15 or higher during inpatient rehabilitation (~15 days post-stroke).
Key inclusion criteria (5 listed)
- Diagnosis of stroke as defined by the WHO: "a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function and persisting longer than 24 hours." Diagnosis of stroke will be confirmed by imaging or clinical diagnosis.
- Age 18 or older.
- Admitted to in-patient rehabilitation.
- National Institutes of Health Stroke Scale (NIHSS) item 1a score <2 (Level of consciousness: 0=alert, 1=not alert, but arousable by minor stimulation to obey, answer, or respond).
- Provision of informed consent by individual or by legally authorized representative.
Key exclusion criteria (9 listed)
- Pre-stroke or current diagnosis of OSA or other sleep-related breathing disorder.
- Living in a nursing home or assisted living center prior to the stroke.
- Unable to ambulate 150' independently prior to the stroke.
- Other neurologic health condition that may impact recovery such as Parkinson Disease, Multiple Sclerosis, Traumatic Brain Injury, Alzheimer's Disease.
- Women who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObserve physical function and sleep disorder symptoms following stroke | Other | SLEEPR cohort |
Primary outcome
Functional independence with activities of daily living as measured by the Barthel index
Time frame: 15 days post-stroke
The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence
Functional independence with activities of daily living as measured by the Barthel index
Time frame: 60 days post-stroke
The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence
Functional independence with activities of daily living as measured by the Barthel index
Time frame: 90 days post-stroke
The Barthel index is a measure of functional independence with activities of daily living; the score ranges 0-100 with higher numbers indicating more independence
Level of disability according to the stroke impact scale
Time frame: 60 days post-stroke
The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function
Level of disability according to the stroke impact scale
Time frame: 90 days post-stroke
The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function
Daytime sleepiness according to the Epworth Sleepiness Scale
Time frame: 15 days post-stroke
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Daytime sleepiness according to the Epworth Sleepiness Scale
Time frame: 60 days post-stroke
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Daytime sleepiness according to the Epworth Sleepiness Scale
Time frame: 90 days post-stroke
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Insomnia severity as determined from the insomnia severity index
Time frame: 15 days post-stroke
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Insomnia severity as determined from the insomnia severity index
Time frame: 60 days post-stroke
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Insomnia severity as determined from the insomnia severity index
Time frame: 90 days post-stroke
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
Time frame: 15 days post-stroke
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
Time frame: 60 days post-stroke
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
Time frame: 90 days post-stroke
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
Time frame: 15days post-stroke
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
Time frame: 60days post-stroke
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
Time frame: 90 days post-stroke
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
31 secondary outcomes
Degree of disability according to the modified Rankin scale
Time frame: 15 days post-stroke
Degree of disability according to the modified Rankin scale
Time frame: 60 days post-stroke
Degree of disability according to the modified Rankin scale
Time frame: 90 days post-stroke
Balance ability according to the Berg balance scale
Time frame: 15 days post-stroke
Balance ability according to the Berg balance scale
Time frame: 60 days post-stroke
Balance ability according to the Berg balance scale
Time frame: 90 days post-stroke
Gait speed
Time frame: 15 days post-stroke
Gait speed
Time frame: 60 days post-stroke
Gait speed
Time frame: 90 days post-stroke
Activity level
Time frame: 15 days post-stroke
Activity level
Time frame: 60 days post-stroke
Activity level
Time frame: 90 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data
Time frame: 60 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data
Time frame: 90 days post-stroke
GG code for Mobility and Self Care Sections
Time frame: 15 days post-stroke
Daily activities as recorded by study participants (trip log)
Time frame: 60-days post-stroke
Daily activities as recorded by study participants (trip log)
Time frame: 90-days post-stroke
Cognitive ability according to the Montreal cognitive assessment
Time frame: 15 days post-stroke
Cognitive ability according to the Montreal cognitive assessment
Time frame: 60 days post-stroke
Cognitive ability according to the Montreal cognitive assessment
Time frame: 90 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
Time frame: 15 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
Time frame: 60 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)
Time frame: 90 days post-stroke
Sleep diary
Time frame: 60 days post-stroke
Sleep diary
Time frame: 90 days post-stroke
Oxygen desaturation index
Time frame: 90 days post-stroke
Oxygen desaturation index
Time frame: 60 days post-stroke
Oxygen desaturation index
Time frame: 15 days post-stroke
Wrist actigraphy data
Time frame: 15 days post-stroke
Wrist actigraphy data
Time frame: 60 days post-stroke
Wrist actigraphy data
Time frame: 90 days post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 42261959Fulk GD, Bell R, Batts K, Klingman K, Peterson E. Sleep Regularity Index After Stroke: Change Over Time and Its Association With Recovery: A Longitudinal Observational Study. J Am Heart Assoc. 2026 Jun 16;15(12):e048392. doi: 10.1161/JAHA.125.048392. Epub 2026 Jun 9.
- Derived from this study: PubMed 40336157Fulk GD, Klingman K, Peterson EN. Fusing GPS, Activity Monitors, and Self-Report to Improve Assessment of Walking Activity and Community Participation After Stroke. J Neurol Phys Ther. 2025 Jul 1;49(3):128-136. doi: 10.1097/NPT.0000000000000518. Epub 2025 May 8.
- Derived from this study: PubMed 35948301Klingman KJ, Skufca JD, Duncan PW, Wang D, Fulk GD. Study Protocol: Sleep Effects on Poststroke Rehabilitation Study. Nurs Res. 2022 Nov-Dec 01;71(6):483-490. doi: 10.1097/NNR.0000000000000611. Epub 2022 Aug 6.
- Individual participant dataSharing planned: Yes. Final research data along with meta-data and descriptors will be shared to the maximum extent possible while protecting patient privacy. Data will be for individual subjects. No aggregate data will be provided apart from what is published in the literature. Data will be formatted for SPSS and/or as csv files.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Klingman, PhD principal investigator
SUNY Upstate Medical University, College of Nursing
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Sleep Wake Disorders, run by State University of New York - Upstate Medical University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen J Klingman, PhD (315-464-4276, klingmak@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence with activities of daily living as measured by the Barthel index (time frame: 15 days post-stroke). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05012605, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.